Deep Capsule® (Deep Capsule US)
K-Number: K250655 · 2026-03-12
Decision Date2026-03-12
Product CodeQZF
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Deep Capsule® (Deep Capsule US) is the device name listed in this FDA 510(k) record. The listed applicant is Digestaid - Artificial Intelligence Development SA. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K250655. The device is classified under product code QZF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Deep Capsule® (Deep Capsule US)?
Deep Capsule® (Deep Capsule US) is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Digestaid - Artificial Intelligence Development SA. The 510(k) number is K250655.
When did Deep Capsule® (Deep Capsule US) receive FDA 510(k) clearance?
Deep Capsule® (Deep Capsule US) received FDA 510(k) clearance on 2026-03-12, under 510(k) number K250655.
Who is the listed applicant for Deep Capsule® (Deep Capsule US)?
The FDA 510(k) record lists Digestaid - Artificial Intelligence Development SA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Deep Capsule® (Deep Capsule US)?
The FDA product code for Deep Capsule® (Deep Capsule US) is QZF.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.